Using Dry Eye As a Disease Model, Investigators Demonstrated the Optimal Selection of Individualized Clinical Interventions and the Superiority of Dynamic Treatment Discrimination in Chinese Medicine.

N/ANot Yet RecruitingNCT06605495

Xuejing Lu4,000 enrolled

Overview

In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, investigators will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

4,000

Conditions

Dry Eye Disease (DED)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be 18-75 years of age and of any gender * Meets Western diagnostic criteria for dry eye * Formed consent and signed the Informed Consent Form Exclusion Criteria: * Those who are unable to perform a dry eye examination due to various factors * Patients with severe diseases of the liver or renal system, or infectious eye diseases * Those who are allergic to the medications used in this study * Women who are pregnant or breastfeeding Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.

Outcomes

Primary Outcomes

Chinese Medical Evidence Scale

The TCM evidence scale converts symptoms and signs into TCM evidence, and assigns 1, 2, and 3 points according to three levels of severity, with reference to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine" and the "International TCM Clinical Practice Guidelines for Stemmed Eyes (2021-12-14)". If the points of TCM evidence are higher or unchanged after the intervention, it means that the intervention measures are ineffective or inefficient, and that patients\' clinical symptoms do not improve significantly or their conditions worsen after the treatment. If the TCM syndrome score increases or remains unchanged after the intervention compared with that before treatment, it means that the intervention is ineffective or inefficient, and the patient\'s clinical symptoms do not improve or worsen after treatment.